3701 1 
Federal Register / Vol. 4<J, No. fll / Wednesday. April 25, 1904 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes ot Health 
Recombinant DNA Research; Actions 
Under Guidelines 
agency: National Institutes of Health, 
PUS. DHHS. 
action: Notice of Actions Under N1H 
Guidelines for Research Involving 
Recombinant DNA Molecules. 
summary: This notice sets forth actions 
taken by the Director, National Institute 
of Ailergy and Infectious Diseases 
(NIAID), by authority of the Director, 
NIH, under the June 1983 NIH 
Guidelines for Research Involving 
Recombinant DNA Molecules (48 FR 
24556). 
effective date: May 25. 1984. 
FOR FURTHER INFORMATION CONTACT: 
Additional information can be obtained 
from Dr. William J. Gartland, Office of 
Recombinant DNA Activities (ORDA), 
National Institutes of Health, Bethesda. 
Maryland 20205, (301) 496-6051. 
SUPPLEMENTARY INFORMATION: Two 
major actions under the NIH Guidelines 
for Research Involving Recombinant 
DNA Molecules are being promulgated 
today. These proposed actions were 
published for comment in the Federal 
Register of January 5, 1984 (49 FR 696J, 
and reviewed and recommended for 
approval by the Recombinant DNA 
Advisory Committee (RAC) at its 
meeting on February 6, 1984. In 
accordance with Section IV-C-l-b of 
the NIH Guidelines, these actions have 
been found to comply with the 
Guidelines and present no significant 
risk to health or the environment. 
Part I of this announcement provides 
background information on the actions. 
Part II provides a summary of the 
actions of the Director, NIAID. 
I. Decision on Actions Under Guidelines 
A. Proposed Amendments of Section III- 
A of the NIH Guidelines 
Messrs. Jeremy Rifkin and Edward 
Lee Rogers, on behalf of the Foundation 
of Economic Trends, Michael W. Fox, 
Environmental Action, Inc., and 
Environmental Task Force, in a letter 
dated November 7, 1983, proposed the 
following amendments to the NIH 
Guidelines. 
1. Proposed Amendment of the 
Section III. The title of Section III of the 
Guidelines would be changed from 
“Containment Guidelines for Covered 
Experiments" to “Guidelines for 
Covered Experiments." 
Messrs. Rifkin and Rogers argued that 
the current title of Section III reflects an 
orientation towards experiments 
contaii'.ed within a laboratory. However, 
the RAC is reviewing experiments 
involving tlce deliberate release into the 
environment of certain organisms 
containing recombinant DNA. Messrs. 
Rifkin and Rogers stated that: 
Accordingly, the focus should no longer be 
on the concept of containment alone, but 
rather on guidelines to assure safety for all 
experiments, whether through containment 
procedures or other techniques. 
2. Proposed Amendment of Section 
lll-A. Messrs. Rifkin and Rogers 
proposed that Section lll-A be amended 
by adding at the end thereof the 
following paragraph: 
A programmatic environmental impact 
statement (EIS) is required under the 
National Environmental Policy Act (NEPA). 
42 U.S.C. 4332, and the Council on 
Environmental Quality Regulations (CEQ 
Regs) implementing NEPA, 40 CFR 1502.1- 
1520.25, for the program involving deliberate 
releases into the environment of recombinant 
DNA molecules. 
Messrs. Rifkin and Rogers in their 
submission provided a detailed 
explanation for this proposed 
modification. 
3. Proposed Additional Amendment of 
Section lll-A. Messrs. Rifkin and Rogers 
proposed that Section III— A be further 
amended by adding after the material 
set forth in the prior amendment the 
following paragraph: 
Individual experiments involving 
deliberate releases into the environment of 
an organism containing recombinant DNA 
require the preparation of either an 
environmental impact statement or an 
environmental assessment. 
In explanation of this proposed 
change, Messrs. Rifkin and Rogers 
stated that: 
Where it is uncertain whether a particular 
experiment may or may not have a significant 
impact on the environment, then, at the least, 
an environmental assessment (EA) must be 
prepared explaining the conclusion reached 
on the question of significant impact, and the 
relevant environmental agencies must be 
involved in that assessment process. See 
CEQ Regs, Sections 1501.3, 1501.4, and 1508.9. 
At issue here are the great variety of 
deliberate-release experiments that have 
potential environmental impacts. 
The proposals by Messrs. Rifkin and 
Rogers were published in the January 5, 
1984, Federal Register (49 FR 696). 
The Director, National Institute of 
Allergy and Infectious Diseases, in the 
January 5, 1984, Federal Register pffered 
the following comments on the 
amendments proposed by Messrs. Rifkin 
and Rogers: 
Hie NIH Recombinant DNA Advisory 
Committee (RAC) does not have the 
responsibility to determine, and it is not 
appropriate for the Mill Guidelines for 
Recombinant DNA Research to state, what is, 
or is not, required by the National 
Environmental Policy Act (NEPA) (42 D.S.C. 
4321 el seq.) and th,e regulations (40 Cf-R Purl 
4500) promulgated by the Council on 
Environmental Quality (CEQ) to assure the 
uniform implementation of that Act. It is not 
the function of the RAC to determine what 
NEPA and the CEQ regulations require. Tho 
RAC is not constituted to interpret points of 
law and the requirements of NEPA. 
Specifically, it is not a function of RAC to 
determine when an environment impact 
statement or an environmental assessment is 
required by NEPA. 
Furthermore, the Foundation on Economics 
Trends, Jeremy Rifkin, Michael W. Fox, 
Environmental Action, Inc., and the 
Environmental Task Force have raised these 
issues in a lawsuit against the Department of 
Health and Human Services, the National 
Institutes of Health, and the National 
Institute of Allergy and Infectious Diseases. 
The suit (Civil Action No. 83-2714) seeks to 
have the United States District Court for the 
District of Columbia decide if additional 
environmental review is required by NEPA 
and the CEQ guidelines with respect to the 
procedures in the Guidelines for NIH 
approval of releases into the environment of 
organisms containing recombinant DNA and 
specific approvals given under those 
procedures. The decision of the District 
Court, or a higher court if an appeal is taken, 
will be binding on all the parties. 
It should also be noted that a proposal 
similar to that now proposed by Messrs. 
Rifkin and Rogers was considered and 
rejected by the Director. NIH, at the time of 
the revision of the NIH Guidelines in 
December 1978. Then NIH Director Donald 
Frederickson wrote in the Federal Register 
(43 FR 90083, December 22, 1978), “Another 
commentator urged that for waiver of the 
prohibition of deliberate release into the 
environment, the Guidelines explicity require 
compliance with the National Environmental 
Policy Act (NEPA) and any additional 
safeguards to be stipulated by EPA. Others 
urged that full Environmental Impact 
Statements be filed on most exceptions to the 
prohibitions. As I noted in my Decision 
accompanying the PRC on July 28, 1978, all 
waiver decisions will include a careful 
consideration of the potential environmental 
impact. Some decisions may be accompanied 
by a formal assessment or statement — a 
determination, however, that can only be 
made on a case-by-case basis. 
Three comments were received on the 
proposals of Messrs. Rifkin and Rogers. 
One commentator wrote, "These should 
be rejected by the RAC for the reasons 
outlined by the Director, National 
Institute of Allergy and Infectious 
Diseases." Another commentator wrote, 
"that a generic environmental impact 
statement or assessment is neither 
proper nor required by law.” A third 
commentator urged that the word 
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